other material
confidence high
sentiment positive
materiality 0.80
Apellis/Sobi Phase 3 VALIANT meets primary endpoint; 68% proteinuria reduction in C3G/IC-MPGN
Apellis Pharmaceuticals, Inc.
- Statistically significant 68% proteinuria reduction vs placebo (p<0.0001) at Week 26.
- Key secondary endpoints met: composite renal endpoint and ≥50% proteinuria reduction.
- Favorable safety profile; no meningitis or serious infections from encapsulated bacteria.
- All VALIANT completers enrolled in long-term extension study VALE.
- Apellis to file sNDA with FDA in early 2025; Sobi to submit EMA application in 2025.